BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

BRIVIACTÂ® (brivaracetam) CV is indicated for the treatment of partial-onset (focal) seizures in patients 4Â years of ageÂ andÂ older.

As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of ageÂ andÂ older).

IMPORTANT SAFETY INFORMATION

BRIVIACT is associated with important warnings and precautions including suicidal behavior and ideation, somnolence, fatigue, dizziness, disturbance in gait and coordination, psychiatric adverse reactions including non-psychotic and psychotic symptoms, and hypersensitivity reactions (bronchospasm and angioedema). BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.

In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients 4 years to less than 16 years of age were generally similar to those in adult patients.

*The precise mechanism by which levetiracetam exerts its anticonvulsant activity is unknown.

â Not all proposed mechanisms of levetiracetam are depicted.

â¡High-voltage-activated calcium channel.

IMPORTANT SAFETY INFORMATION

Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.

Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of adult patients taking at least 50 mg per day of BRIVIACT compared to 14% of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of adult patients taking at least 50 mg per day of BRIVIACT compared to 10% of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.

Efficacy

Efficacy was established in trialsÂ that did not utilize a titrationÂ period

See more

PERCENT REDUCTION OVER PLACEBO IN PARTIAL-ONSET SEIZURE FREQUENCY ADJUSTED TO 28 DAYS DURING THEÂ TREATMENTÂ PERIOD1

Statistically significant based on testing procedure with alpha = 0.05.

Effectiveness was established in adults in 3 fixed-dose, randomized, double-blind, placebo-controlled, multicenter
studies, which included 1550 patients

Enrolled patients had partial-onset seizures that were not adequately controlled by 1 to 2 concomitant antiepileptic
drugs (AEDs)

BRIVIACTÂ® was studied in a challenging patient population

IMPORTANT SAFETY INFORMATION

Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50Â mg per day of BRIVIACT compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.

Efficacy was observed among patients taking BRIVIACTÂ® who had previously discontinued levetiracetam

See more

PERCENT REDUCTION OVER PLACEBO IN PARTIAL-ONSET SEIZURE FREQUENCY ADJUSTED TO 28 DAYS DURING THEÂ TREATMENTÂ PERIOD3

Statistically significant based on testing procedure with alpha = 0.05.

Patients had to discontinue levetiracetam use more than 90 days priorÂ toÂ screening.

In Study 3, approximately 54% of patients had prior exposure to levetiracetam and were evaluated in a pre-specified analysisâ 1,3

Of prior levetiracetam patients, approximately 68% had failed levetiracetam due to efficacy, 14% had discontinued for an adverse drug reaction, and 20% had discontinued for other reasons3

Patients taking concomitant levetiracetam were excluded from the study1

IMPORTANT SAFETY INFORMATION

Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.

Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

There was no apparent dose-dependent increase in adverse reactions with the exception of somnolence and sedation1

Most adverse events in trials were reported to be mild to moderate3

Across all 3 trials, discontinuation rates due to adverse events were1:

Placebo: 4%

BRIVIACT 50Â mg/day: 5%

BRIVIACT 100Â mg/day: 8%

BRIVIACT 200Â mg/day: 7%

The most common adverse reaction leading to discontinuation was dizziness.3

Drug Interactions

See more

General drug interactions1

Rifampin: Co-administration with rifampin decreases BRIVIACTÂ® plasma concentrations likely because of CYP2C19 induction. Increase the BRIVIACT dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage)

None of the interactions listed below requires changes in the dose of BRIVIACT, but interactions with carbamazepine and phenytoin can be clinically important

Carbamazepine: Co-administration may increase exposure to carbamazepine-epoxide (the active metabolite of carbamazepine). Available data did not reveal any safety concerns, but dose reduction should be considered if tolerability issues arise

Phenytoin: BRIVIACT can increase plasma concentrations of phenytoin, so levels should be monitored during co-administration

At a supratherapeutic dose of 400 mg/day brivaracetam, there was a 20% increase in phenytoin plasma concentration

Levetiracetam: BRIVIACT provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered

Dosing IN ADULT PATIENTS (16Â YEARS ANDÂ OLDER)

BRIVIACTÂ® offers a therapeutic dose on DAY ONE

The recommended starting dose for monotherapy and adjunctive therapy is 50 mg twice daily (100 mg/day) and is initiated without titration1

Dose adjustments are not required for patients with impaired renal function; there are no data in patients with end-stage renal disease undergoing dialysis, and use of BRIVIACT is not recommended in this patient population

DOSING IN PEDIATRIC PATIENTS (4Â YEARSÂ TOÂ <16Â YEARS)

The recommended dosing regimen is dependent upon body weight and is only recommended to be administered orally. Please click 8253153458 for the dosing information in the Prescribing Information.

BRIVIACTÂ® is available in multiple formulations, allowing for dosing flexibility

Considerations for tablets and oral solution1

BRIVIACT can be given with or without food

Tablets should be swallowed whole with liquid; they should not be chewed or crushed; tablets are not scored

Considerations for intravenous (IV) use*1

BRIVIACT injection may be used when oral administration is temporarily not feasible.

As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16Â years of ageÂ andÂ older).

Preparation

BRIVIACT injection can be administered intravenously without further dilution or may be mixed with diluents listed below:

0.9% sodium chloride injection, USP

Lactated Ringer's injection

5% dextrose injection, USP

Administration

BRIVIACT injection should be administered intravenously over 2 to 15Â minutes

Adverse reactions with BRIVIACT injection are generally similar to those observed with BRIVIACT tablets and also include dysgeusia, euphoric mood, feeling drunk, and infusion site pain.

â 10-mg tablets are available for down titration.

Blood levels1

No blood-level monitoring required

Pharmacokinetic profile1

Approximately 100% oral bioavailability

Linear pharmacokinetics

The half-life (t1/2) is approximately 9Â hours, steady-state reached after 2Â days

BRIVIACT is weakly bound (â¤20%) to plasma proteins

No pharmacologically active metabolites

*Clinical study experience limited to 4Â consecutive days of treatment.

Co-pay/Savings

Affordability and accessibility matter

UCB is committed to making BRIVIACT accessible for the majority of eligible patients across the US

9 out of 10 commercial patients have formulary access to BRIVIACTÂ® (brivaracetam)Â CV and most have unrestricted access.3

Savings

BRIVIACTÂ® Patient Savings Program

Eligible patients* pay as little as $20 per 30-day supply of BRIVIACT with the BRIVIACT Patient Savings Program

Ask your sales representative for details about the program.

*Patients are responsible for a minimum of $20 out-of-pocket expense per 30-day supply. This card will then be applied toward any remaining out-of-pocket expense up to a maximum of $100. Most patients who have commercial prescription insurance are eligible. If you have any questions regarding your eligibility or benefits or if you wish to discontinue your participation, call the BRIVIACT Savings Program at 1-888-786-5879 (8:30 AM â 5:30 PM EST, Monday-Friday and 8:30 AM â 2:30 PM EST, Saturday). This savings card is not valid for use by patients who are covered by any federal or state funded healthcare program (including, but not limited to, Medicare [Part D and Medigap], Medicaid, any state pharmaceutical assistance program TRICARE, VA, or DoD). Offer good only in the U.S., including Puerto Rico. This card is good for use only with a valid BRIVIACT prescription at the time the prescription is filled by the pharmacist and dispensed to the patient. The maximum annual benefit amount is $1300 per calendar year. Void where prohibited by law, taxed, or restricted. This offer cannot be combined with any other promotional offer. UCB, Inc. reserves the right to rescind, revoke, or amend this offer without notice at any time. No cash value. Not eligible for sale, purchase, trade, or counterfeit.

Assistance

When a prior authorization is required, PARx SolutionsÂ® and CoverMyMedsÂ® can provide assistance

PARx Solutions and CoverMyMeds offer prior authorization (PA) assistance through an electronic-based system that standardizes the medical necessity request process for most insurance providers, and for patients with commercial, Medicare Part D, and Medicaid coverage*

When a prior authorization is needed, PARx Solutions and CoverMyMeds can provide assistance.

If a prescription is submitted to a participating pharmacy and requires a PA, CoverMyMeds facilitates the approval process by delivering a PA to your office for completion, signature, and submission to the health plan

More than 90%14 of retail pharmacies participate in CoverMyMeds

Physician-initiated PAs

CoverMyMeds also offers a web-based portal that can help your office by automating the PA process, saving prescribers and staff time and ensuring patients receive their medication faster

*Currently, Medi-Cal, Washington State Medicaid, and Wisconsin State Medicaid require the pharmacy to submit prior authorization forms and may not be applicable to this program. This list is subject to change based on plan requirements.

â Year-to-date average does not indicate or guarantee an individualâs approval for BRIVIACT.

Financial assistance may be available for BRIVIACTÂ® patients

The BRIVIACT Patient Assistance Program may be able to help if your patients do not have health insurance or if they are a Medicare Part D recipient and cannot afford BRIVIACT. Eligible patients are provided a free 6-month supply of medicine and can reapply every six months for continuing support.

To learn more about the BRIVIACT Patient Assistance Program or to find out if your patient might be eligible for assistance, please contact UCBCares at dissociant or 4849976705, or click below to get started.

Receive a FREE 2-week trial ofÂ BRIVIACTÂ®

Important Safety Information

WARNINGS AND PRECAUTIONS

Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcareÂ provider.

Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25%Â of adult patients taking at least 50Â mg per day of BRIVIACT compared to 14%Â of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16%Â of adult patients taking at least 50Â mg per day of BRIVIACT compared to 10%Â of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience onÂ BRIVIACT.

Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13%Â of adult patients taking at least 50Â mg per day of BRIVIACT compared to 8%Â of adult patients taking placebo. A total of 1.7%Â of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3%Â of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcareÂ provider.

Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactiveÂ ingredients.

Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and statusÂ epilepticus.

DOSING CONSIDERATIONS

Dose adjustments are recommended for patients with all stages of hepatic impairment.

When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients 4Â years to less than 16Â years of age were generally similar to those in adult patients.

If you have any questions or want more information, please contact UCBCares at 1-844-599-CARE (2273) or UCBCares@UCB.com. Weâre here to help.

You are about to leave BRIVIACTHCP.com.

You are about to leave BRIVIACTHCP.com and are being redirected to an external website. UCB is not responsible for the content or services of that site or any further links from that site. Do you wish to continue?